FDA 510(k) Application Details - K984196

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K984196
Device Name System,Planning,Radiation Therapy Treatment
Applicant SSGI PROWESS SYSTEMS
1370 RIDGEWOOD DR., #20
CHICO, CA 95973-7803 US
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Contact ROBERT J MORTON
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 11/23/1998
Decision Date 12/11/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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